Clinical Trials Register

Summary
EudraCT Number:	2011-002001-30
Sponsor's Protocol Code Number:	IMUP
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-12
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2011-002001-30

A.3

Full title of the trial

Multicenter, prospective, double-blind, two-armed phase III study for efficacy and safety of the topic impetigo therapy of two 2 % mupirocin ointments

Multizentrische, prospektive, doppelblinde, zweiarmige Phase III-Studie zur Wirksamkeit und Sicherheit der topischen Impetigo-Therapie zweier
2%-iger Mupirocin-Salben

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Multicenter, prospective, double-blind, two-armed phase III study for efficacy and safety of the topic impetigo therapy of two 2 % mupirocin ointments

Multizentrische, prospektive, doppelblinde, zweiarmige Phase III-Studie zur Wirksamkeit und Sicherheit der topischen Impetigo-Therapie zweier
2%-iger Mupirocin-Salben

A.3.2

Name or abbreviated title of the trial where available

Impetigo therapy safety of two mupirocin ointments

Impetigo-Therapie-Wirksamkeit zweier Mupirocin-Salben

A.4.1

Sponsor's protocol code number

IMUP

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	INFECTOPHARM Arzneimittel und Consilium GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	INFECTOPHARM Arzneimittel und Consilium GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	INFECTOPHARM Arzneimittel und Consilium GmbH
B.5.2	Functional name of contact point	Dr. Bertil Wachall
B.5.3	Address:
B.5.3.1	Street Address	Von-Humboldt-Str. 1
B.5.3.2	Town/ city	Heppenheim
B.5.3.3	Post code	64646
B.5.3.4	Country	Germany
B.5.4	Telephone number	+496252958104
B.5.5	Fax number	+496252958852
B.5.6	E-mail	studien@infectopharm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	InfectoMupi Salbe 2 %
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Mupirocin
D.3.9.1	CAS number	12650-69-0
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	Pseudomoninsäure A
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Bactroban 2 % ointment
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline UK
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bactroban 2 % ointment
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Mupirocin
D.3.9.1	CAS number	12650-69-0
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	Pseudomoninsäure A
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Impetigo

E.1.1.1

Medical condition in easily understood language

highly infectious bacterial skin infection

Hochinfektiöse bakterielle Hautinfektion

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Clinical cure at the final examination on Day 14

Klinische Heilung bei der Abschluss-Visite an Tag 14

E.2.2

Secondary objectives of the trial

- Microbiological cure at the final examination on Day 14
- Clinical cure on Day 7
- Microbiological cure on Day 7
- Termination due to inefficacy on Day 3
- SIRS (Skin Infection Ratin Scale) on Day 7 and Day 14
- Change in SIRS score from baseline on Day 7, from baseline to Day 14 and from Day 7 to Day 14

- Mikrobiologische Heilung (kein S. aureus- und kein S. pyogenes-Nachweis im bakteriologischen Abstrich) bei der Abschlussvisite an Tag 14
- Klinische Heilung an Tag 7
- Mikrobiologische Heilung an Tag 7
- Abbruch aufgrund von Unwirksamkeit an Tag 3
- SIRS (Skin Infection Ratin Scale) an Tag 7 und Tag 14
- SIRS-Veränderung von Baseline zu Tag 7, Baseline zu Tag 14und Tag 7 zu Tag 14

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Written informed consent of both parents/legal guardians
- Clinically diagnosed impetigo
- Skin Infection Rating Scale SIRS ≥ 4
- ≥ 3 SIRS categories existing
- Detection of staphylococcus aureus and/or streptococcus pyogenes in the initial swab from the affected spot
- 28 days up to 15 years of age

- Schriftliche Einwilligung beider Eltern/Erziehungsberechtigten und ggf. des Patienten
- Klinisch diagnostizierte Impetigo
- Skin Infection Rating Scale SIRS ≥ 4
- ≥ 3 SIRS-Kategorien vorhanden
- Erregernachweis für Staphylococcus aureus und/oder Streptococcus pyogenes beim initialen Abstrich von der betroffenen Stelle
- Alter von 28 Tagen bis 15 Jahre

E.4

Principal exclusion criteria

-Necessity of a systemic therapy with antibiotics due to the severity and/or expansion of the impetigo or of a concomitant infection
- Extensively infected skin areas
-Affection of critical body regions as the auditory canal and the corner of the eye
-Impetigo as a secondary infection of a bite injury
- Impetigo in the area of central venous catheters
- Intranasally located impetigo
-Dermatological diseases that could impair the assessment of the impetigo (e. g. ecthyma, furunculosis, abscess, contact dermatitis, bite injuries)
-Clinically relevant primary or secondary immunodeficiency
-Current or less than 6 months dating back malign tumour diseases, chemotherapy, or radiotherapy
-Inadequately adjusted clinically relevant diabetes
- Known moderate or severe renal insufficiancy
-Other severe diseases that the investigator assesses as conflicting with the participation
-Systemic or dermal therapy with antibiotics, antimycotics, or corticoids during the past 7 days
-Dermal application of antiseptics during the past 7 days
-Girls of child-bearing potential
-Known intolerance to macrogol or mupirocin
- Inability of the parents to understand the instructions of the study
- Obvious unreliability of the parents or missing willingness to cooperate
- Known addiction of the parents to alcohol, medicaments, or drugs
- Limited legal competence of the parents or juricically/regulatorily ordered commitment to an institution
- Dependency of the child or the parents on the sponsor or on an investigator
- Participation in a clinical trial during the past 30 days
- Previous participation in the present clinical trial

- Notwendigkeit einer systemischen Antibiotika-Therapie aufgrund der Schwere und /oder Ausdehnung der Impetigo oder einer Begleitinfektion
- Großflächig infizierte Hautpartien
- Befall kritischer Regionen wie Gehörgang und Augenwinkel
- Impetigo als Sekundärinfektion einer Bissverletzung
- Impetigo im Bereich eines zentralen Venenkatheters
- Impetigo mit intranasaler Beteiligung
- Dermatologische Erkrankungen, die die Bewertung der Impetigo beeinträchtigen könnten (z.B. Ekthymata, Furunkulose, Abszess, Kontaktdermatitis, Bissverletzungen)
- Klinisch relevant primäre oder sekundäre Immundefizienz
- Bestehende oder weniger als 6 Monate zurückliegende maligne Tumorerkrankungen, Chemo- oder Strahlentherapie
- Unzureichend eingestellter, klinisch relevanter Diabetes
- Bekannte mäßige oder schwere Niereninsuffizienz
- Sonstige schwerwiegende Erkrankungen, die einer Teilnahme nach Einschätzung des Prüfarztes entgegen stehen
- Systemische oder dermale Antibiotika-, Antimykotika- oder Kortikoidtherapie in den letzten 7 Tagen
- Dermale Anwendung von Antiseptika in den letzten 7 Tagen
- Mädchen im empfänglichen Alter
- Bekannte Überempfindlichkeit gegen Macrogol oder Mupirocin
- Unfähigkeit der Eltern, die Studienanweisungen zu verstehen
- Offensichtliche Unzuverlässigkeit oder fehlende Kooperationsbereitschaft der Eltern
- Bekannte Alkohol-, Medikamenten- oder Drogenabhängigkeit der Eltern
- Beschränkte Geschäftsfähigkeit oder gerichtlich/behördlich angeordnete Unterbringung der Eltern in einer Anstalt
- Abhängigkeit des Kindes oder der Eltern vom Sponsor oder einem Prüfarzt
- Teilnahme an einer klinischen Prüfung in den letzten 30 Tagen
- Vorausgegangene Teilnahme an der selben Studie

E.5 End points

E.5.1

Primary end point(s)

Clinical cure at the final examination on Day 14

Klinische Heilung bei der Abschluss-Visite an Tag 14

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 14/Tag 14

E.5.2

Secondary end point(s)

Efficacy
-Microbiological cure at the final examination on Day 14
-Clinical cure on Day 7
-Microbiological cure on Day 7
-Termination due to inefficacy on day 3
-SIRS (Skin Infection Rating Scale) on Day 7 and Day 14
-Change in SIRS score from baseline to Day 7, from baseline to Day 14, and from Day 7 to Day 14

Tolerance
-Adverse events by nature of the event, System Organ Class, severity, and causality
-Serious adverse events by nature of the event, System Organ Class, and causality
-Side effects
-Dropouts

Wirksamkeit
- Mikrobiologische Heilung (kein S. aureus- und kein S. pyogenes-Nachweis im bakteriologischen Abstrich) bei der Abschlussvisite an Tag 14
- Klinische Heilung an Tag 7
- Mikrobiologische Heilung an Tag 7
- Abbruch aufgrund von Unwirksamkeit an Tag 3
- SIRS (Skin Infection Rating Scale) an Tag 7 und Tag 14
- SIRS-Veränderung von Baseline zu Tag 7, Baseline zu Tag 14 und
Tag 7 zu Tag 14

Verträglichkeit
- Unerwünschte Ereignisse nach Art, System Organ Class, Schweregrad und Kausalität
- Schwerwiegende unerwünschte Ereignisse nach Art, System Organ Class und Kausalität
- Nebenwirkungen
- Drop outs

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 3 and/or Day 7 and/or Day 14
Tag 3 und/oder Tag 7 und/oder Tag 14

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

120

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Infants, toddlers, and children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After completion of the participation in the clinical trial (completion of the 7-day intervention phase and the 7-day follow-up phase) every patient gets the most appropriate individual therapy according to his current symptomatology and the decision of the physician in charge, taking into account the guidelines of the relevant associations and the current standard of medical knowledge.

Nach Beendigung der Teilnahme an der klinischen Prüfung (Abschluss der 7-tägigen Interventions- und 7-tägigen Follow-Up-Phase) erhält jeder Patient entsprechend seiner aktuellen Symptomatik die an den Vorgaben der Fachgesellschaften und dem aktuellen Stand der medizinischen Erkenntnis orientierte, nach Maßgabe des ihn betreuenden Arztes bestgeeignete individuelle Behandlung.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-10-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-06-07

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